Medication Safety in Clinical Trials: Role of the Pharmacist in Optimizing Practice, Collaboration, and Education to Reduce Errors

Abstract

Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates multiple mechanisms to promote safety and improve the quality of clinical research. This is accomplished through collaborating in the development of a research protocol, reviewing as a member of an advisory committee, developing mechanisms that contribute to safety, and assuring compliance with local and national regulations and standards. Ultimately, the profession of pharmacy has foundational responsibility for assuring the safe and effective use of medications, including investigational drugs in clinical research. It is through multidisciplinary collaboration that a research study will attain the highest standards for safety and maximize the quality and effectiveness of the data obtained in the clinical trial.

Keywords: clinical trials; investigational drug service; patient safety; pharmacy practice; research pharmacist.

Figure 1

Safety Concerns of Investigational Drug Packaging. A. Bottles contain black and white print lacking differentiating features such as unique color or font. Note use of “bottle number” or “container number” which identifies specific units to distribute to a particular study subject. Lengthy, sequential numbering may increase risk for selecting an incorrect bottle. B. Lack of differentiation in investigational drug naming may lead to confusion. Note active and placebo drugs are named almost identically: “aripiprazole tab 5 mg” and “aripiprazole tab plbo” C. Individual or multiple vials may be required to prepare a single dose of injectable medication. With such a variable volume range, a pharmacist may be less likely to detect an error in dosing compared to unit of use vials. D. Tablets and capsules of identical appearance for placebo-controlled studies may arrive in bulk containers. Large quantities not only require more storage space, but also lead to risk of contamination of the entire supply if product is introduced into the wrong container during dispensing.